Thermo IEC Installation Qualification and Operation Qualification

Customer:

Centrifuge: Centra-GP8

Serial No*.:

Prepared By: Thermo IEC

Verified By: Date:

Approved By: Date:

QUALIFICATION

Verified By: Date:

Approved By: Date:

FINAL REVIEW

Operation: Date:

Quality Control: Date:

*Serial Number can be found on the data plate, located next to the power entry
module on the left side of the centrifuge:

data plate

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Thermo IEC Installation Qualification and Operation Qualification

PROTOCOL

Installation Qualification describes the installation of the centrifuge, as well as

configuration, if necessary. If need be, any peripheral devices permanently
assigned to it can be documented on supplementary sheets.

Operation Qualification describes a test of the guaranteed performance data of

the centrifuge, ensuring that it performs to all of the manufacturers
specifications.

The material in this publication is for information purposes only. The contents and the
product it describes are subject to change without notice. Thermo IEC makes no
representations or warranties with respect to this manual. In no event shall Thermo IEC
be held liable for any damages, direct or incidental, arising out of or related to the use of
this manual.

TERMINOLOGY

Calibration describes the relationship between the indicated quantity of measure

and the actual quantity using either a certified and traceable reference or
measuring device. There is no adjustment to calibration of this model centrifuge.

Certification designates that the indicated quantity of measure is within accuracy

(or tolerance) specifications of the actual quantity.

Accuracy (or Tolerance) is the extreme range of values of error allowed by

manufacturers specifications for a traceable reference or measuring device.

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Thermo IEC Installation Qualification and Operation Qualification

INSTALLATION QUALIFICATION

Unpacking Centrifuge
n/a Yes No
Verify contents: Centrifuge
Power Cord
Operation Manual

Optional Accessories: Rotor(s)

Buckets
Adapters
Instruction Sheet

Record Optional Accessories:

Note: All accessory numbers and weights are stamped somewhere on their surface.
Maximum speeds can be found in the Operation Manual in the section Speed &
Force Tables.

Rotor Number Max. RPM

Buckets No. Qty. Weight
Adapters No. Qty. Weight
Yes No
Do all bucket weights match?
Do all adapter weights match?

Rotor Number Max. RPM

Buckets No. Qty. Weight
Adapters No. Qty. Weight
Yes No
Do all bucket weights match?
Do all adapter weights match?

Rotor Number Max. RPM

Buckets No. Qty. Weight
Adapters No. Qty. Weight
Yes No
Do all bucket weights match?
Do all adapter weights match?

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Thermo IEC Installation Qualification and Operation Qualification

Location

Dept. Bldg. Room

Yes No
Is the centrifuge placed on a clean dry surface?

Is the surface rigid, level and stable?

Is there clearance of at least 8 cm (3 in) at the rear and on both sides of the
centrifuge?

Are the suction cup feet properly engaging the surface?

Power Configuration

Verify the supplied electrical power at the location of centrifuge installation:

Voltage: VAC Frequency: Hz

Yes No
Is this the proper operating voltage, amperage and phase according
to the Operation Manual or data plate?

Is the power supply a grounded (3-prong) electrical outlet?

Completed By: Date:

Title:

Approved By: Date:

Title:

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Thermo IEC Installation Qualification and Operation Qualification

OPERATION QUALIFICATION

Control Panel

Yes No
Does pressing the ON/OFF key toggle the display lights?
(Not including STOP light)

Does pressing the RPM/RCF up and down arrow keys change the
RPM/RCF display?
Does pressing the RPM/RCF key toggle the red RPM & RCF LED light?

Does pressing the TIME up and down arrow keys change the TIME display?

Does pressing the ROTOR up and down arrow keys change the ROTOR
display?
Does pressing the ROTOR/RADIUS key toggle the red ROTOR & RADIUS LED
light?
Does pressing the ACCELERATION SLOW key decrease the number of
orange LED lights between fast (5) and slow (1)?
Does pressing the ACCELERATION FAST key increase the number of
orange LED lights between slow (1) and fast (5)?
Does pressing the DECELERATION SLOW key decrease the number of
orange LED lights between fast (5), slow (1) and coast (none)?
Does pressing the DECELERATION FAST key increase the number of
orange LED lights between coast (none), slow (1) and fast (5)?
Does pressing the COVER OPEN key release the centrifuge cover?

Completed By: Date:

Title:
Approved By: Date:
Title:

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Thermo IEC Installation Qualification and Operation Qualification

Rotor
Yes No
Do all rotors install properly onto the shaft? (See Operation Manual)

Do all rotors reach maximum speed according to specifications?

Operating and Timing Modes

Yes No
Does pressing the PROGRAM key save the displayed program?
(Note: First, select a program number, and change the temp, time or speed. Saving is
confirmed when the program number stops blinking.)

Does pressing the PROGRAM arrow keys allow selection of the following
Operating Modes:
Manual Blank Display
Program 1-35
Hold H

Select Manual Operating Mode (blank PROGRAM display).

Select the At Start Timing Mode by pressing the TIME down arrow key and
scrolling down past 0:00, pressing it again until ACC is displayed. Press the up
arrow key until 5:00 is displayed.
Press the RPM/RCF arrow keys to set a speed (within maximum rated
speed range for the rotor installed).

Press the START key . Does the centrifuge time display begin to count down
as soon as START is pressed?

Press the STOP key .

Select the At Speed Timing Mode (SPd in TIME display). Press the START
key . Does the centrifuge time display begin to count down as soon as 95% of
set speed is achieved?

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Thermo IEC Installation Qualification and Operation Qualification

Starting and Stopping A Run

Select Manual Operating Mode (blank PROGRAM display).

Select a time by pressing the TIME arrow keys and scrolling until 5:00 is
displayed.
Press the RPM/RCF arrow keys to set a speed (within maximum rated
speed range for the rotor installed).

Press the START key . Yes No

Does the red STOP LED go out, and the green START LED come on?
Does the green START LED blink until set speed is reached?

Press the STOP key .

Does the green START LED go out, and the red STOP LED come on?
Does the red STOP LED blink until 0 RPM speed is reached?

Select the Hold Timing Mode (H in PROGRAM display). Press the

START key . Does the centrifuge time display count up until the
STOP key is pressed?

Completed By: Date:

Title:

Approved By: Date:

Title:

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Thermo IEC Installation Qualification and Operation Qualification

Warning Messages
Yes No
With the cover open, press the START key .
Does the centrifuge display the Lid warning message?
Does closing the cover clear this message?

Install a rotor, and during a run, unplug the power cord and plug it back in.
Does the centrifuge display the PFAIL warning message?
Does pressing the STOP key clear this message?

Note: The following test can cause damage to the motor. Be prepared to press the STOP
key as the centrifuge approaches 2000 rpm.

Place a 75-gram imbalance weight into one of the buckets and press the START
key .
Does the centrifuge display the bAL warning message before
reaching 2000 rpm?
Does opening the cover clear this message?

Cover Interlock Bypass

Yes No
Unplug the centrifuge and locate the hidden plug just below the front control
panel. Pry it out and pull on the attached cord. Does the cover open?

Completed By: Date:

Title:

Approved By: Date:

Title:

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Thermo IEC Installation Qualification and Operation Qualification

Performance

Accuracy: Speed +/- 10 RPM

Time +/- 1 second

Speed Test

Set Speed Measured Speed Display Speed

1.
2.
3.
Yes No
Does the centrifuge maintain and display set speed
within specified accuracy?

Time Test

Set Time Measured Time Display Time

1.
2.
3.
Yes No
Does the centrifuge maintain and display set time
within specified accuracy?

Completed By: Date:

Title:

Approved By: Date:

Title:

IQ/OQ Rev. 12/01 Model: Centra-GP8 Centrifuge Page 9

Thermo IEC Installation Qualification and Operation Qualification

Traceable References or Measuring Devices

Reference or Device Model Serial No. Certified?

Yes No
1.

2.

3.

Notes:

CONCLUSION
Yes No
Based on the results documented in this manual, the centrifuge
is working according to Manufacturers Specifications?

Completed By: Date:

Title:

Approved By: Date:

Title:

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